SYNTHES USA

Manufacturer adverse-event records for SYNTHES USA come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1994–2022 · heavy-book · typical Death-code · injury-heavy

Injury-mix signature

SYNTHES USA leans injury-heavy in event_type mix

Injury-coded event_type share is 76.5% (injury-heavy tercile) beside 0.16% Death-coded (typical). Volume band: heavy.

What the Injury-mix reading shows for SYNTHES USA

The standout signal for SYNTHES USA is Injury-mix: 76.5% Injury-coded (injury-heavy) beside 0.16% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair SYNTHES USA with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 20 device types, led in this extract by Injury at 16,839 (76.5% of event_type total). Peak single-year volume reaches 5,765 reports across 29 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

22,000
Total Reports
36
Event-type Death
16,839
Injury Reports
20
Device Types

Event Types

Injury 16,839 (76.5%)
Malfunction 5,099 (23.2%)
Death 36 (0.2%)
Other 15 (0.1%)
11 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 16,643 (75.4%)
5,173 (23.4%)
Other 96 (0.4%)
R 48 (0.2%)
Death 46 (0.2%)
Hospitalization 31 (0.1%)
O 15 (0.1%)
Disability 6 (0.0%)
Congenital Anomaly 5 (0.0%)
L 1 (0.0%)
S 1 (0.0%)

Yearly Trend

94
1994: 1
95
1995: 3
96
1996: 16
97
1997: 10
98
1998: 21
99
1999: 11
00
2000: 13
01
2001: 7
02
2002: 3
03
2003: 1
04
2004: 6
05
2005: 1
06
2006: 2
07
2007: 2
08
2008: 1
09
2009: 6
10
2010: 9
11
2011: 37
12
2012: 1,687
13
2013: 5,765
14
2014: 3,296
15
2015: 5,343
16
2016: 4,051
17
2017: 1,693
18
2018: 5
19
2019: 3
20
2020: 2
21
2021: 3
22
2022: 2